NCT05390606

Brief Summary

This study intends to address whether improving the vaginal microbiome can help couples increase chances of conceiving.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

May 18, 2022

Last Update Submit

June 29, 2025

Conditions

InfertilityInfertility Unexplained

Outcome Measures

Primary Outcomes (3)

  • Conception at home

    Percentage of women becoming pregnant at home within the 3 month study.

    3 months

  • Change in vaginal microbiome

    Vaginal microbiome composition tested by next-generation sequencing

    Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.

  • Change in vaginal pH

    Vaginal pH tested by vaginal fluid applied to pH test strip

    Baseline to end of active study period, which is either at 3 months or upon confirmation of pregnancy, whichever occurs first.

Secondary Outcomes (5)

  • Conception within one year

    15 months

  • Rate of live birth

    24 months or fewer

  • Gestational age at delivery

    24 months or fewer

  • Birthweight at delivery

    24 months or fewer

  • Rates of pregnancy complications

    24 months or fewer

Study Arms (2)

Control arm

NO INTERVENTION

Women follow routine care only, including prescribed medications and recommended techniques and supplements for attempting to become pregnant at home for up to three months.

Flourish HEC + BioGenesis arm

EXPERIMENTAL

In addition to routine care followed by women in control arm, women in this arm also use the Flourish HEC (Hydroxyethylcellulose) vaginal care system and BioGenesis fertility lubricant for up to three months.

Combination Product: Flourish HEC and BioGenesis

Interventions

Flourish HEC and BioGenesisCOMBINATION_PRODUCT

Flourish HEC is a 3-component system, including: 1) Balance feminine wash, used daily; 2) BioNourish vaginal moisturizer, used daily before bed except if having intercourse; 3) BiopHresh homeopathic vaginal suppository with probiotics, used once every 3 days before bed except if having intercourse. BioNourish is a class II medical device with FDA 510k clearance, on the market for 2 years. BioGenesis is also a class II medical device with FDA 510k clearance, and is designated as a fertility lubricant, safe for sperm and embryos.

Flourish HEC + BioGenesis arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women part of a cisgender couple aged 18 to 40 who are attempting to become pregnant and are attending a fertility clinic.

You may not qualify if:

  • Pregnant
  • Lactating
  • Severe male factor, hormonal imbalance (oligoovulatory/anovulatory cycles, cycles longer than 35 days), genetic abnormalities (chromosomal abnormality, common genetic mutation between partners), or severe uterine or tubal factor
  • Any diagnosis that would require the participant to undergo in vitro fertilization to become pregnant
  • Known allergies to any component of BioNourish®, Balance, BiopHresh®, or BioGenesis™
  • Known active vaginal infection at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Aimee Eyvazzadeh

San Ramon, California, 94583, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Metabolism

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Aimee Eyvazzadeh, MD, MS, MBA

    Dr. Aimee Eyvazzadeh, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A longitudinal open label randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 25, 2022

Study Start

June 15, 2022

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)